Key Points

In the Italian phase II PURE-01 trial reported in the Journal of Clinical Oncology, Necchi et al found that neoadjuvant pembrolizumab (Keytruda) before radical cystectomy in muscle-invasive bladder carcinoma produced complete pathologic response (pT0) in 42% of patients, with pT0 being more common in patients with higher programmed cell death ligand 1 (PD-L1) expression.

In the study, 50 patients from two sites in Milan were enrolled between February 2017 and March 2018 and received three cycles of pembrolizumab at 200 mg every 3 weeks before radical cystectomy. Patients had a predominant urothelial carcinoma histology and clinical (c)T≤3bN0 stage tumors. Overall, 27 patients (54%) had cT3 tumors, 21 (42%) had cT2 tumors, and 2 (4%) had cT2-3N1 tumors.

The investigators concluded, “Neoadjuvant pembrolizumab resulted in 42% of patients with pT0 and was safely administered in patients with [muscle-invasive bladder carcinoma]. This study indicates that pembrolizumab could be a worthwhile neoadjuvant therapy for the treatment of [muscle-invasive bladder carcinoma] when limited to patients with PD-L1–positive or high-TMB tumors.”

The study was supported by Merck and a grant from Associazione Italiana per la Ricerca sul Cancro.

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.